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Regulatory Affairs Specialist II
4 months ago
As a Regulatory Affairs Specialist within the Genetic Science Division (GSD) and Clinical Next-Generation Sequencing Division (CSD), you will play important role in impacting patient's life and improve global health outcome. Your expertise will contribute in maintaining the regulatory compliance of the organisation and ensuring our product meets the relevant regulatory requirements.
Tasks and Functions:
Partner with global, regional and local team members to ensure timely product registrations in SEA region.
Prepare accurate submission dossier based on CSDT, or other relevant formats.
Ensure license are maintained in accordance with commercial needs. Tasks includes re-registration, renewal, amendment, change notification, etc.
Report MDR/ Adverse Event/FSCA/Recall to regulatory authorities, if needed.
Review labelling and promotional materials for regulatory compliance.
Ensure the registration records and database are properly maintained.
Support regulatory intelligence related assignment.
Adhere to procedures to ensure compliance with ISO 13485, MDSAP, US FDA, IVDR, and ISO 9001 standards.
Handle other works assigned by supervisor.
Education and qualification
Bachelor’s degree or higher degree in Engineering, Sciences, or comparable field.
Minimum 4 years of meaningful experience in regulatory affairs related to In Vitro Diagnostic (IVD) Devices and/or Medical Devices.
Knowledge, Skills, Abilities
In-depth knowledge in IVD/medical devices regulations, standards and guidelines in SEA.
Excellent communication, written, verbal and presentation skills, particularly in regulatory affair applications.
Ability to work effectively across cultures and functions.
Strong analytical skills and attention to details.
Systematic in handling multiple registration work.
Able to work under pressure and flexible working hours based on business requirements.
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
